Reported Jul 1, 2026 · Ongoing · Updated Sep 16, 2026
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product…
Abiomed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 22 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
- Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP
- Impella Set Product Code1000434
- Introducer Product Code1000434
- Lot codes and dates
- Impella Set Product Code1000434
- GTIN00813502012996
- Serial NumbersN/A
- Introducer Product Code1000434
- Batch Number2038639
- Amount recalled
- 3 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
Potential for thrombus formation during prolonged use of the introducer.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Abiomed, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.